At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 284 enrolled
Drug / intervention
Armour® Thyroid +1 moredrug
Likely dose
Levothyroxine 200 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Dose-conversion Study to Evaluate the Safety and Efficacy of Hormone Replacement Therapy With Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Who Are Euthyroid on T4 Replacement Therapy
In Brief
A Phase 2 clinical trial evaluating Armour® Thyroid and Levothyroxine for Hypothyroidism and 4 related conditions. Completed, enrolled 284 participants across 28 sites.
Detailed Summary
This study will evaluate the safe and effective dose conversion from levothyroxine (synthetic T4) therapy to Armour Thyroid therapy in participants who are on a stable dose of levothyroxine and have thyroid stimulating hormone (TSH) levels within the normal reference range.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothyroidism, Thyroid Disease, Euthyroid, Thyroid Gland, Thyroid Hormones
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartOct 2019
Primary CompletionJun 2021
TodayJul 2026
First PostedOct 11, 2019
Enrollment StartOct 11, 2019
Primary CompletionJun 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.7 years ago
Interventions
Armour® Thyroiddrug
Administered orally once a day. the daily dose could range from 1/4 - 2 grains.
Levothyroxinedrug
Administered orally once a day; the daily dose could range from 25- 200 µg.